慢性非癌痛的阿片类药物治疗：一项随机对照试验的系统评价方案。
Opioids for chronic non-cancer pain: a protocol for a systematic review of randomized controlled trials.
机构信息
Department of Anesthesia, McMaster University, Hamilton, Canada.
出版信息
Syst Rev. 2013 Aug 21;2:66. doi: 10.1186/2046-4053-2-66.
BACKGROUND
Opioids are prescribed frequently and increasingly for the management of chronic non-cancer pain (CNCP). Current systematic reviews have a number of limitations, leaving uncertainty with regard to the benefits and harms associated with opioid therapy for CNCP. We propose to conduct a systematic review and meta-analysis to summarize the evidence for using opioids in the treatment of CNCP and the risk of associated adverse events.
METHODS AND DESIGN
Eligible trials will include those that randomly allocate patients with CNCP to treatment with any opioid or any non-opioid control group. We will use the guidelines published by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) to inform the outcomes that we collect and present. We will use the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) system to evaluate confidence in the evidence on an outcome-by-outcome basis. Teams of reviewers will independently and in duplicate assess trial eligibility, abstract data, and assess risk of bias among eligible trials. To ensure interpretability of our results, we will present risk differences and measures of relative effect for all outcomes reported and these will be based on anchor-based minimally important clinical differences, when available. We will conduct a priori defined subgroup analyses consistent with current best practices.
DISCUSSION
Our review will evaluate both the effectiveness and the adverse events associated with opioid use for CNCP, evaluate confidence in the evidence using the GRADE approach, and prioritize patient-important outcomes with a focus on functional gains guided by IMMPACT recommendations. Our results will facilitate evidence-based management of patients with CNCP and identify key areas for future research.
TRIAL REGISTRATION
Our protocol is registered on PROSPERO (CRD42012003023), http://www.crd.york.ac.uk/PROSPERO.
背景
阿片类药物经常被用于治疗慢性非癌痛（CNCP），且使用量呈上升趋势。目前的系统评价存在一些局限性，导致阿片类药物治疗 CNCP 的获益和危害仍存在不确定性。我们拟进行一项系统评价和荟萃分析，以总结阿片类药物治疗 CNCP 的证据以及相关不良反应的风险。
方法和设计
合格的试验将包括那些将 CNCP 患者随机分配到阿片类药物或任何非阿片类药物对照组治疗的试验。我们将使用临床试验方法、测量和疼痛评估倡议（IMMPACT）发布的指南来告知我们收集和呈现的结果。我们将使用推荐分级、评估、制定与评价（GRADE）系统对每个结局的证据进行信心评估。审查团队将独立并重复评估试验的纳入标准、提取数据，并评估合格试验的偏倚风险。为了确保我们的结果具有可解释性，我们将报告所有报告结局的风险差异和相对效果测量值，这些值将基于可用的基于锚定的最小临床重要差异。我们将按照当前最佳实践进行事先定义的亚组分析。
讨论
我们的综述将评估阿片类药物治疗 CNCP 的有效性和不良反应，使用 GRADE 方法评估证据的可信度，并根据 IMMPACT 建议，以功能获益为重点，优先考虑患者重要结局。我们的研究结果将有助于为 CNCP 患者提供循证管理，并确定未来研究的关键领域。
试验注册
我们的方案已在 PROSPERO（CRD42012003023）注册，网址为：http://www.crd.york.ac.uk/PROSPERO。
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